Return of individual genomic research results: are laws and policies keeping step? View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-01-08

AUTHORS

Adrian Thorogood, Gratien Dalpé, Bartha Maria Knoppers

ABSTRACT

Efforts are underway to harmonise the return of individual results and incidental findings from whole genome sequencing (WGS) across research contexts and countries. We reviewed international, regional and national laws and policies applying to return across 20 countries to identify areas of convergence and divergence. Discrepancies between laws and policies are most problematic where they cannot be reconciled through harmonisation of project-level governance. Rules for the return of results apply at different levels in different jurisdictions (e.g., human subjects research, biobanks, clinical trials, genomic sequencing, and genetic/personal data), complicating comparison. A particular concern for harmonisation are the (often contradictory) rules about when results must, should, may, or must not be returned. Adding confusion are different thresholds for utility (medical, familial, reproductive, and/or personal). The importance of respecting individual choices to know or not know is widely recognised, though some norms emphasise respect for personal preferences. Another troubling observation is that requirements for data quality, variant assessment, and the effective communication of results are evolving in uneven ways. There is a growing gap between researchers with the expertise, infrastructure, and resources to meet these requirements and those without, threatening international collaboration. Best practices for the return of individual genomic results are sorely needed to inform not only the ethical return of results, but also future legislative and policy efforts. More... »

PAGES

535-546

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/s41431-018-0311-3

DOI

http://dx.doi.org/10.1038/s41431-018-0311-3

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1111269787

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30622328


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